Treatment of Acute Periprosthetic Total Hip Arthroplasty Infections

OrthoCarolina Research Institute, Inc.

Status: Withdrawn

Conditions: Periprosthetic Infection Total Hip Arthoplasty

Treatments: Procedure: one stage exchange; Procedure: open debridement with modular exchange

Study type: Interventional

Funder types: Other

Identifiers

NCT01712880

12055

Details and patient eligibility

About

The purpose of this study is to determine the success rate of two treatments for infection after total hip replacement: single stage arthroplasty exchange (your surgeon will take out your original implants and replace them with a complete new set) compared to irrigation and debridement with modular exchange (your surgeon will clean your implants with a surgical solution and take out the plastic liner and replace it with a new one - the rest of your hip implants will stay in place). The goal is to see if one is better than the other for the treatment of hip infection after a total hip replacement. A successful treatment means that you did not have to have another surgery on your hip for an infection-related reason.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Return to the OR for a drainage procedure within six weeks of index primary uncemented arthroplasty 1a) Exam findings within six weeks of index operation:

   • Drainage for more than 7 days
   • Wound appearance consistent with deep infection or hematoma
   • Persistent fever or evidence of bacteremia
   • All patients currently deemed appropriate for irrigation and debridement

2. Labs

   • Rising inflammatory seromarkers

3. Aspiration with a positive culture

Exclusion criteria

1. Previous history of periprosthetic infection
2. Prisoners
3. Patients not willing to consent for the proposed treatment
4. Patients with altered mental status
5. Concurrent metastatic infection
6. Superficial Infection

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

open debridement with modular exchange

Active Comparator group

Treatment:

Procedure: open debridement with modular exchange

one stage exchange

Active Comparator group

Treatment:

Procedure: one stage exchange